Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical (Score-TIH)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.

During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.

Condition or disease
Heparin-induced Thrombocytopenia

Detailed Description:

Purpose : To create and validate a score predicting the diagnosis of HIT

Study Design

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Study Type :	Observational
Actual Enrollment :	2700 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)
Study Start Date :	March 2009
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	November 2012

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests [ Time Frame: inclusion and 40 days after the inclusion ]

Secondary Outcome Measures :

1. pathogenic nature of anti HPF4 antibodies of IgM and IgA type [ Time Frame: inclusion ]
2. new biological test detecting HIT [ Time Frame: inclusion ]

Biospecimen Retention:   Samples Without DNA

blood sample

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

community sample

Criteria

Inclusion Criteria:

• all patients presenting, either during or immediately after treatment:

  • thrombocytopenia and/or venous or arterial thrombosis
  • for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study

Exclusion Criteria:

• do not possess sufficient clinical data prior to performance of the biological test
• cannot assure follow-up of the patient until normalization of the platelet count

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
ETS de Franche Conté - Laboratoire d'Immuno Hématologie
Besançon, France, 25020
CHU Cavale Blanche Laboratoire d'Hématologie
Brest, France, 29609
Laboratoire d'hématologie - Hôpital Louis Pradel
Bron, France, 69500
Hôpital Antoine Beclère - Laboratoire d'hématologie
Clamart, France, 92141
Laboratoire d'hématologie - CHU de Clermont Ferrand
Clermont Ferrand, France, 63003
HCC Colmar - laboratoire d'hématologie
Colmar, France, 68024
Laboratoire d'Hématologie - CHU le Bocage
Dijon, France, 21034
Laboratoire d'hémostase - CCML
Le Plessis Robinson, France, 92350
Hôpital Cardiologique - Laboratoire d'Hémostase
Lille, France, 59037
CHU La Timone - Laboratoire Hématologie
Marseille, France, 13385
Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie
Montpellier, France, 34295
Hématologie biologique - CHU Nancy
Nancy, France, 54511
HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie
Nantes, France, 44093
Hématologie Biologique - Hôpital Tenon,
Paris, France, 75002
Hôpital Necker Enfants Malades -Laboratoire d'Hématologie
Paris, France, 75015
Hôpital BICHAT - Service d'hématologie immunologie
Paris, France, 75018
G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran
Paris, France, 75851
Hôpital Européen Georges Pompidou - Service Hématologie Biologique A
Paris, France, 75908
Hôpital Cardiologique - CHU Bordeaux
Pessac, France, 33604
Laboratoire central d'hématologie - Hôpital R. DEBRE
Reims, France, 51092
CHU de ROUEN
Rouen, France, 76031
Laboratoire d'hématologie
Saint-Etienne, France, 42055
Service d'Urgence et de Réanimation
Saint-Etienne, France, 42055
CHU Strasbourg Hautepierre Laboratoire d'Hématologie
Strasbourg, France, 67098
CMC Foch Laboratoire d'hémostase
Suresnes, France, 92151
Hopital Purpan - Laboratoire d'hématologie
Toulouse, France, 31059
CHU Trousseau - CTH - Service d'Hématologie Hémostase
Tours, France, 37044

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Hyphen BioMed

CIC-EC de Saint-Etienne

Groupe d'étude sur l'Hémostase et la Thrombose

Association Française des centres régionaux de Pharmacovigilance

Laboratoires Organon

Sanofi

Investigators

Principal Investigator:	Bernard TARDY, MD	CHU de Saint-Etienne

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00748839 History of Changes
Other Study ID Numbers:	0801016
First Posted:	September 9, 2008
Last Update Posted:	November 27, 2012
Last Verified:	November 2012

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

HIT; Heparin-induced thrombocytopenia; heparin treatment; venous thrombosis	arterial thrombosis; predictive clinical score; biological test; anti-H-PF4 antibodies

Additional relevant MeSH terms:

Thrombosis; Thrombocytopenia; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders; Hematologic Diseases	Calcium heparin; Heparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action